FDA 510(k) Application Details - K014104

Device Classification Name

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510(K) Number K014104
Device Name VACUETTE EDTA K2 TUBES
Applicant GREINER VACUETTE NORTH AMERICA, INC.
P.O. BOX 103
BALDWIN, MD 21013 US
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Contact Judi Smith
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Regulation Number

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Classification Product Code PJE
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Date Received 12/13/2001
Decision Date 02/01/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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